Senior Director, Evidence Generation Biostatistics

Summary

This position serves as the Biostatistics Evidence Generation Head for US Operations.

• The incumbent will be responsible for supervision and strategic input to the entire evidence generation plan for all assigned projects as well as to US Business Unit.
• The position is accountable for the development of statistical strategy and deliverables, developing statistical expertise, promoting innovations in clinical studies, maintaining operational excellence and building efficient processes and standards with the primary purpose of accelerating worldwide product adoption.
• This position will represent the function in global product teams in Medical Affairs, CSPV and Market Access functions as well as in Health Technology authority meetings.
• The position is responsible for resource planning/allocation, timeline management and prioritization for statistical deliverables.
• The position is also accountable for people management, including performance and development of direct reports.
• The position holder will show strong statistical leadership, strategic thinking and excellent communication skills for the interactions with internal and external stakeholders.

Responsibilities

- Business Leadership and People Management

• Lead Evidence Generation Strategy for US Business Unit. Ensure appropriate and proactive networking with key stakeholders, understand incoming business needs, implement Evidence Generation vision and strategy in US Business Unit.
• Support development and implementation of Global Evidence Generation Strategy. Identifies technology and business needs to proactively meet incoming business as well as improve harmonization and efficiency for cost savings and accelerated worldwide evidence generation product development and access.
• Administrative responsibilities for recruiting, retaining, developing, and managing employees.
• Author or initiate writing of global standard operating procedures for statistics functions. Oversee and ensure compliance of standard procedures and processes.

- Global Evidence Generation Compound Lead

• Act as project statistician for MA, CSPV, HTA and HEOR activities for at least one compound. As project statistical expert contributes to evidence generation and publication plan to ensure overall biostatistical strategy can deliver according to business needs and pre-specified product profile. Briefs senior management on assigned projects or studies as needed. Subject matter expert in one or more therapeutic areas.
• Act as statistical expert in the assigned projects. Ensures that statistical activities for evidence generation are scientifically sound and that the evidence generated meets requirements of internal (Medical Affairs and HEOR) as well as external stakeholders (KOLs, HTA and pricing agencies). Drives the utilization of most efficient and innovative study designs and statistical techniques to maximize the success of the drug product.
• Act as project statistician and is accountable for all the biostatistical deliverables performed by direct report or from biostatisticians assigned to its project across the global / regional evidence generation activities. Ensures consistency in data collection, derived data definition, statistical analysis and result interpretation throughout the project. Leads planning and analysis of integrated efficacy and safety data.

- Biostatistical Activities

• Leads statistical activities globally for very complex studies. This includes at least the development of study protocols, analysis plans and analysis execution and interpretation for clinical studies, non-interventional studies, as well as other studies within scope.
• Leads the development and execution of statistical activities for scientific publication from the planning throughout its execution. Ensures clear and scientifically sound interpretation of publications from a statistical perspective.
• Leads statistical activities on a global and regional basis for pricing authorities submissions and interactions. This includes at least the development of project and payer analysis plans and analysis execution and interpretation of the analyses within scope as well as contribute to biostatistical elements of value dossier, cost effectiveness model and other HEOR deliverables. The position holder may represent Daiichi Sankyo in pricing authorities interactions for biostatistical activities.

- External Vendor Oversight

• Manage higher-level negotiation and provides oversight of budget, resources and timelines with con-tract research organizations (CROs) for multiple projects across the department and ensures timely delivery of high quality deliverables at reasonable cost

- Statistical Innovation and Operational Excellence

• Lead Global Biostatistical Innovation for activities outside the Regulatory perimeter.
• Develop and implement global vision and strategy to leverage statistical innovation. Identify innovation opportunities, creates and leverage network with academic institutions, develop and implement internship program to attract new talents in collaboration with department operational and innovation requirements.
• Leads global Evidence Generation initiatives to improve the harmonization and efficiency of processes by coordinating the work of an assigned team of experts.
• Keep himself/herself abreast on statistical methodological, regulatory or pricing topics

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)
- PhD in Statistics or Biostatistics or Mathematics required

Experience Qualifications

- 10 or more years of experience in pharmaceutical industry in drug development or evidence generation of which at least 3 in evidence generation space is preferred
- 4 or more years Supervisory experience of managing a team preferred
- 4 or more years extensive experience in Oncology or Cardiovascular Therapeutic Area in conducting clinical programs and studies is preferred
- 4 or more years experience in late phase projects is preferred. preferred
- 4 or more years experience in programming in SAS and/or R preferred

Travel

Ability to travel up to 10% Ability to travel domestic and international